Description

Cefuroxime Impurity 12 is a specified impurity and reference standard used in the analytical profiling of the antibiotic Cefuroxime. This compound is critical for pharmaceutical quality control and regulatory compliance, ensuring the purity and safety of the final drug product. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers involved in the development, production, and quality assurance of Cefuroxime and related cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefuroxime Impurity 12 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities during the drug manufacturing process.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure Cefuroxime batches meet stringent pharmacopeial standards (e.g., USP, EP, ICH guidelines) for impurity limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions to establish drug shelf life.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research and Development: Facilitates research into the synthesis pathways, degradation mechanisms, and metabolic profiles of Cefuroxime.

Basic Information

Product Name	Cefuroxime Impurity 12
CAS No.	37051-06-2
Molecular Formula	C16H16N4O8S
Molecular Weight	424.39 g/mol
Synonyms	(6R,7R)-3-[(Carbamoyloxy)methyl]-7-[[(2Z)-2-(2-furyl)-2-(methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; 7-[2-(2-Furyl)-2-(methoxyimino)acetamido]-3-[(aminocarbonyl)oxy]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefuroxime Related Compound B; Cefuroxime Impurity B; Cefuroxime EP Impurity B; Cefuroxime USP Related Compound B
EINECS	Contact for details

Quality Control

Our Cefuroxime Impurity 12 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR), to ensure it meets the high standards required for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.